After carefully reviewing nominations for these three substances, FDA did not identify sufficient support to include these drugs on the list Under Section 503B of the FD&C Act, outsourcing facilities generally cannot compound drugs using bulk substances unless they appear on the 503B bulks list or the drug is on FDA's shortage list A determination of clinical need is based on patient safety and medical necessity under the law We want to hear from you
Mediation analysis from the STEP trials found that of the additional 7.6-14.4% weight loss achieved with semaglutide versus placebo, less than 1 percentage point was mediated by gastrointestinal adverse events
Drug Res (Stuttg)
Clinical trials report diarrhea in 15% to 20% of semaglutide users, making it one of the more common but typically temporary gastrointestinal effects
Zou Y, Palte MJ, Deik AA, Li H, Eaton JK, Wang W, et al
Genetic insights should be interpreted with a qualified healthcare provider and aviation medical examiner to inform safe, personalized options
